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On February 22, 2019, the Department of Health and Human Services issued a final rule to revise the regulations governing the Title X family planning program.

Background

Title X is the only federal program dedicated solely to the provision of family planning and related preventive services tailored to individual needs, with priority given to those from low income families. Established in 1970, the program provides funding “to assist in the establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents).”1

Pursuant to Congressional mandate, family participation is to be encouraged, particularly in services involving adolescents. And, from the start, Congress was clear that Title X funds cannot be used to support abortion.2

The Title X program serves approximately 4 million clients every year. This final rule ensures that grants and contracts awarded under this program fully comply with the statutory program integrity requirements, thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.

Summary of Final Rule

The regulations governing the Title X program have not been substantially updated since 2000. Since then, the need to clarify and ensure compliance with the statutory intent of the program has only increased. The major provisions of the 2019 Title X regulation are summarized below.

Ensures program integrity, consistent with statutory purpose.

Prohibits the use of Title X funds to perform, promote, refer for, or support abortion as a method of family planning.

Permits, but no longer requires, nondirective pregnancy counseling, including nondirective counseling on abortion.

Provides for clear financial and physical separation between Title X and non-Title X activities, reducing any confusion on the part of Title X clinics and the public about permissible Title X activities between the two.

Improves program transparency by requiring more complete reporting by grantees about subrecipients and more clarity about informal partnerships with referral agencies, to ensure provision of quality family planning services and compliance with statutory and regulatory requirements.

Increases accountability, ensuring that grant recipients and their sub-recipients understand permissible and impermissible activities under the Title X program.

Overall, ensures the program is consistent with the underlying statute.

Summary: Of particular significance, the 2019 regulation focuses on compliance with the underlying Title X statute. In addition, it provides clarity between permissible Title X activities and impermissible ones by requiring clear financial and physical separation for Title X funded programs from programs and facilities where abortion is a method of family planning.

Protects the patient/healthcare provider relationship.

Removes the requirement for abortion referral, replacing it with a prohibition on referral for abortion as a method of family planning.

Permits, but no longer requires, nondirective pregnancy counseling, including on abortion.

Requires referrals for those conditions deemed medically necessary.

Ensures conscience protections for Title X health providers by eliminating the requirement for providers to counsel on and refer for abortion.

Summary: The 2019 regulation places a high priority on preserving the patient/healthcare provider relationship, in order to promote optimal health for every Title X patient. As such, it requires medically necessary referrals, such as referrals for prenatal care. To preserve open communication between the patient and the healthcare provider, the regulation permits, but no longer requires, nondirective pregnancy counseling, including nondirective counseling on abortion. Consistent with the statutory requirement that no funds may be expended where abortion is a method of family planning, this regulation no longer requires, and affirmatively prohibits, referral for abortion as a method of family planning.

Protects women and children from victimization.

Ensures compliance with state reporting laws and consistency of care for women who visit Title X clinics and are victims of sexual abuse, intimate partner violence, incest, or human trafficking.

Ensures that children who visit Title X clinics and are victims of rape, incest, child abuse, child molestation, or human trafficking are protected under the law.

Requires that minors be counseled on how to resist coercion to engage in sexual activity.

Summary: This final rule includes a stronger focus on protecting women and children from being victimized by child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and trafficking. The regulation requires all Title X clinics to provide annual training for staff and to have a site-specific protocol in place to report crime and protect victims.

Boosts meaningful family communication, especially in adolescent family planning.

Meaningfully encourages parent/child communication in family planning decisions, and requires documentation of such encouragement.

Summary: Almost 1 in 5 Title X clients are adolescents. This final rule requires clinics to meaningfully encourage parent/child communication. As required by law, Title X clinics must encourage family participation in family planning decision-making, particularly a minor’s decision to seek family planning services. As part of counseling of minors, they should provide practical ways to begin – and maintain – such communication.

Expands coverage, partnerships and innovation.

Focuses on innovative approaches to expand Title X services to unserved and underserved areas.

Improves Title X services by encouraging diverse and non-traditional Title X partners.

Prioritizes innovation, partnerships and expansion of the number served by changes in selection criteria for grant proposals.

Clarifies that those unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employer’s religious beliefs or moral conviction may be considered for Title X services.

Summary: The final rule adds provisions that are designed to increase the number of patients served within the Title X program by placing special focus on reaching more unserved or underserved areas, by increasing innovation within the program, expanding diversity of grantees and partners, and clarifying the flexibility that program directors have to provide services to those in need of family planning services.

Returns Title X flexibility to states and other grantees.

Restores States’ ability to prioritize funding according to the needs of the populations.

Formally revokes the 2016 rule, which put unnecessary restrictions on states and other grantees and which had been rendered void by a joint resolution of disapproval passed by Congress under the Congressional Review Act and signed by the President.

Summary: The final rule officially revokes a 2016 Title X regulation that limited the ability of States and other Title X grantees to exercise flexibility in choosing their subrecipients. This frees grantees to select clinical providers that meet the Title X needs of their patients, consistent with local needs and sensibilities, and within the statutory and regulatory guidelines.

Effective Date: The final rule takes effect 60 days after its publication in the Federal Register.

Compliance with the physical separation requirements contained in § 59.15 is required is one year after publication in the Federal Register.

Compliance with the financial separation requirements contained in § 59.15 is required 120 days after publication in the Federal Register.

Compliance with § 59.7, the deletion of § 59.5(a)(10)(i), and compliance with § 59.5(a)(13) is required 120 days after publication in the Federal Register.

Compliance for reporting, assurance, and provision of service in § 59.5(a)(12), § 59.5(a)(13) as it applies to all required reports, § 59.5(a)(14), § 59.5(b)(1), § 59.5(b)(8), § 59.13, § 59.14, § 59.17, and § 59.18 is required 120 days after publication in the Federal Register.

Compliance with new requirements concerning applications will be effective during the next application period.

Compliance for all other requirements of this final rule is required 60 days after publication in the Federal Register.

The U.S. Department of Health and Human Services (HHS) today issued the final rule to revise the regulations governing the Title X family planning program, which focuses on serving low-income Americans.

The final rule ensures compliance with statutory program integrity provisions governing the program and, in particular, the statutory prohibition on funding programs where abortion is a method of family planning. The final rule amends the Title X regulation, which had not been substantially updated in nearly two decades, and makes notable improvements designed to increase the number of patients served and improve the quality of their care.

A proposed rule regarding the Title X program was published in the Federal Register on June 1, 2018, with a 60-day public comment period. The Department received and carefully reviewed more than 500,000 comments, and made certain changes to the final rule as a result of its consideration of the comments.

The Title X program annually serves approximately 4 million people, and the updated rule seeks to ensure a holistic and health-centered approach, safeguarding the short- and long-term family planning needs of more women, men, and adolescents in need of services. Key elements of the final rule include:

Requiring clear financial and physical separation between Title X funded projects and programs or facilities where abortion is a method of family planning. This separation will ensure adherence to statutory restrictions, and provide needed clarity for the public and for Title X clinics about permissible and impermissible activities for Title X projects.

Prohibiting referral for abortion as a method of family planning. The final rule does not bar nondirective counseling on abortion, but eliminates the requirement that Title X providers offer abortion counseling and referral. It protects Title X healthcare providers so that they are not required to choose between participating in the program and violating their own consciences by providing abortion counseling and referral.

Improving program transparency by requiring more complete reporting by grantees about subrecipients and more clarity about informal partnerships with referral agencies, to ensure provision of quality family planning services and compliance with statutory and regulatory requirements.

Requiring that Title X clinics provide annual training for staff and have a site-specific protocol in place to protect victims/survivors of sexual assault.

Requiring compliance with State and local laws on reporting or notification of these crimes.

Requiring counseling for minors on how to resist attempts to coerce them into sexual activities.

Requiring clinics to encourage meaningful parent/child communication – and, as required by federal law, to encourage family participation, especially in a minor’s decision to seek family planning services – and to provide practical ways to begin (and maintain) such communications.

Maintaining the confidential relationship between patients and medical professionals within the statutory requirements.

Clarifying that individuals may be considered for Title X services if they are unable to obtain employer-sponsored insurance coverage for certain contraceptive services due to their employer’s religious beliefs or moral convictions and the limitations of their own financial resources.

Providing high quality comprehensive family planning services to those currently unserved or underserved, while ensuring the integrity of the Title X program, consistent with statutory requirements.

Today, Health and Human Services Secretary Alex Azar issued the following statement on President Trump’s Fiscal Year 2020 Budget:

“The President’s budget makes necessary investments and bold reforms to deliver on HHS’s mission, and supports the hard work the men and women of HHS are already doing to improve the health and well-being of the American people. The budget will advance HHS’s work on increasing the affordability of individual health insurance, bringing down the price of prescription drugs, transforming our healthcare system into one that pays for value, and combating the opioid crisis. It also provides historic new funding dedicated to one of the most important public health initiatives undertaken this century: President Trump’s plan to end the HIV epidemic in America by 2030. This budget will help deliver on the President’s vision for a fiscally sustainable federal budget, a stronger economy, and a healthier America.”

Today, President Trump proposed $291 million in the FY2020 HHS budget to begin his Administration’s multi-year initiative focused on ending the HIV epidemic in America by 2030. This new initiative aims to reduce new HIV infections by 75 percent in the next 5 years and by 90 percent in the next 10 years, averting more than 250,000 HIV infections in that span.

Recent data show our progress reducing the number of new HIV infections has plateaued, and there are new threats to the progress that has been made, the most significant being the opioid crisis: 1 in 10 new HIV infections occur among people who inject drugs.

Ending the HIV Epidemic: A Plan for America, announced by the President in his State of the Union address on February 5, 2019, is a bold approach that is the result of decades of work, and focuses on four key strategies that, together, can end the HIV epidemic in the U.S. The funding requested, based on careful consideration by our top scientists and public health officials, targets four areas of action:

Diagnose all individuals with HIV as early as possible after infection.

Protect individuals at risk for HIV using proven prevention approaches.

Respond rapidly to detect and respond to growing HIV clusters and prevent new HIV infections.

The time to act is now. We have the right data, the right tools, and the right leadership to end the HIV epidemic in America—a goal once thought impossible but now within our reach. The initial investment announced today will undoubtedly help to reverse current, troubling trends and put us on a committed pathway to ending the HIV epidemic for our next generation.